First Patient In Deep Brain Stimulation For Alzheimer’s Study

In short

A first patient has been successfully implanted with Medtronic’s DBS device as Functional Neuromodulation Ltd initiates the ADvance Study in the U.S. and Canada to assess the therapy in patients with mild Alzheimer’s disease. ADvance will evaluate the safety and potential clinical benefit of DBS of the fornix (DBS-f), a major inflow and output pathway in the brain’s memory circuit. Research suggests this is an area affected early in the development of Alzheimer’s.

Background

36 million people worldwide are reportedly living with dementia, with numbers expected to approximately double every 20 years to 66 million by 2030 and 115 million by 2050. The worldwide costs of dementia (US$604 billion in 2010) amount to more than 1% of global GDP with Alzheimer’s the sixth-leading cause of death and the only cause of death among the top 10 causes in the United States without an identified way to prevent, cure or even slow its progression. In this context, its not hard to see why there is a global quest for a solution.

Deep Brain Stimulation (DBS) uses a surgically implanted medical device, similar to a cardiac pacemaker, to deliver mild electrical pulses to precisely targeted areas of the brain. The extent of the therapy’s approval status varies across the world, with more than 85,000 people worldwide have received treatment for conditions ranging from Parkinson’s disease to refractory epilepsy.

Canadian company Functional Neuromodulation Ltd is dedicated to advancing the application of DBS therapies to help improve the lives of people with Alzheimer’s and other memory and cognitive disorders. The Company has entered into a partnership with Medtronic, under which Medtronic is providing its state-of-the-art DBS devices for the ADvance Study and access to Medtronic’s related device regulatory filings.

The study

With financial backing from Medtronic, ADvance is a randomised double-blind controlled trial initially involving 20 people aged 55-80 with mild Alzheimer’s disease. The trial will compare the effects of DBS turned on to those observed with the system turned off. The patients will undergo regular physiological, psychological and cognitive assessments for 12 months at which time those patients in the off group will be eligible to have the system activated. Brain imaging measures of changes in glucose metabolism and the size of key structures involved in memory will also be assessed at multiple time points.

ADvance is informed by a pilot study which reported increased glucose metabolism in key brain networks after stimulation, indicating an increase in neuronal activity and better functional connectivity in areas affected by Alzheimer’s. At one year, this increase in brain metabolism correlated with better outcomes in cognition, memory and quality of life.

Investigator comments

“DBS-f delivers stimulation to a critical location in the brain’s memory circuit that seems to enhance activity in the circuit and drive neuronal activity in other brain regions impacted by Alzheimer’s. ADvance will enable us to assess further whether stimulating the brain with DBS-f can drive neural activity in a way that might lead to better clinical outcomes,” commented Dr. Lyketsos, ADvance national co-chair.

Company comments

“As people are increasingly aware, there is an urgent need for new and better ways to treat Alzheimer’s. DBS is a promising new approach that has a successful track record in a number of other brain disorders,” said Dan O’Connell, Functional Neuromodulation co-founder and CEO. “We have worked closely with a stellar group of scientific, clinical and regulatory experts to design ADvance as a feasibility study to determine if DBS-f could constitute a new circuitry-based approach to treating this devastating disease. We look forward to expanding the study to more leading Alzheimer’s centers in the U.S.”

Regulatory status

DBS-f is limited by Federal law to investigational use.

SOURCE: Functional Neuromodulation, Ltd